NARCOWORK: Evaluation of Academic and Professional Trajectories of Narcoleptic Patients

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03173378

Collaborator

(none)

149

Enrollment

Location

9.2

Actual Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an important handicap in everyday life, and are often misunderstood by the family and professional environment. In addition, many comorbidities are associated with narcolepsy, such as depression, anxiety, or obesity.

Few studies have examined the impact of narcolepsy on patients' educational background, socio-professional integration, and quality of life. In particular, the factors of professional handicap related to the characteristics of the disease and the determinants of the insertion of the patients remain poorly known.

As a better understanding of these determinants could help to inform patients and guide them in their choices, NARCOWORK study aims at evaluating the academic and professional trajectories of a wide population of narcoleptic patients.

Condition or Disease	Intervention/Treatment	Phase
Narcolepsy	Other: Questionnaires

Study Design

Study Type:

Observational

Actual Enrollment :

149 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Evaluation of Academic and Professional Trajectories of Narcoleptic Patients

Actual Study Start Date :

Oct 3, 2017

Actual Primary Completion Date :

Jul 10, 2018

Actual Study Completion Date :

Jul 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Narcoleptic Patients Type 1 and Type 2 narcoleptic adult patients usually followed at the Lyon Sleep Medicine and Respiratory Disease center	Other: Questionnaires Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)
Control Adult age-matched family members of the patients	Other: Questionnaires Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)

Arm

Intervention/Treatment

Narcoleptic Patients

Type 1 and Type 2 narcoleptic adult patients usually followed at the Lyon Sleep Medicine and Respiratory Disease center

Other: Questionnaires

Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)

Control

Adult age-matched family members of the patients

Other: Questionnaires

Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)

Outcome Measures

Primary Outcome Measures

Occupational situations [30 to 45 minutes]
Participants will have to complete questionnaires to compare the distribution of occupational situations subjects (worker, unemployed, student, retired, housewife) in narcoleptic patients and matched non-narcoleptic subjects (controls)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Group "Narcoleptic Patients":

Type 1 or Type 2 narcolepsy
18 years
Usually followed at the Lyon Sleep Medicine Center

Group "Control":

At least one member of each family of cases (siblings, cousins ...)
18 years and of the same age as the case if possible (+/- 5 years)
No narcolepsy

Exclusion Criteria:

uncertain diagnosis (for the "Narcoleptic Patients" Group)
poor knowledge of the French language
Refusal to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon		France	69004

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03173378

Other Study ID Numbers:

69HCL17_0252

First Posted:

Jun 1, 2017

Last Update Posted:

Nov 28, 2018

Last Verified:

Nov 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Narcolepsy

Study Results

No Results Posted as of Nov 28, 2018